Radiation Exposure Reduction in Supraventricular Tachycardia Ablation (NO-PARTY)

This study has been completed.
Sponsor:
Collaborators:
St. Jude Medical Italy (Research Grant)
CNR Institute of Clinical Physiology, Pisa, Italy
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01132274
First received: March 4, 2010
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

Radiofrequency catheter ablation (RFCA) is the mainstay of therapy for supraventricular tachyarrhythmias, providing cure in a high percentage of cases. Conventional ablation techniques require the use of fluoroscopy to place and navigate catheters in the heart, thus exposing patients to ionizing radiations with an additional risk of cancer. The feasibility and safety of a non-fluoroscopic RFCA of a wide range of supraventricular arrhythmias using the EnSite NavX mapping system have been recently reported. The NO-PARTY is a multicenter, randomized-controlled trial designed to test the hypothesis that supraventricular arrhythmias RFCA through the non-fluoroscopic EnSite NavX mapping system results in a clinically significant reduction of the exposure to ionizing radiations compared with conventional ablation techniques.

NO-PARTY trial will determine whether supraventricular tachyarrhythmia RFCA through a non-fluoroscopic EnSite NavX mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction of ionizing radiation exposure for both the patient and the operator.


Condition Intervention Phase
Supraventricular Tachycardias
Procedure: Radiofrequency catheter ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • reduction of ionizing radiation exposure [ Time Frame: 1 day (radiation exposure will be evaluated at the end of procedure) ] [ Designated as safety issue: No ]
    the NO-PARTY trial was designed to compare a non-fluoroscopic catheter ablation guided by the EnSite NavXTM mapping system with conventional catheter ablation for supraventricular tachyarrhythmias in terms of ionizing radiation exposure for both the patient and the operator


Secondary Outcome Measures:
  • Cost-Effectiveness [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    The total reduction in fluoroscopy use with the non-fluoroscopic NavX mapping system approach is associated with a life-term ionizing radiation-exposure risk reduction, which will be estimated according to currently available ionizing radiation risk charts. Cost-effectiveness analysis will be performed taking into account such risk reduction, and the increased costs associated with the use of the nonfluoroscopic radiofrequency ablation approach.

  • Cost-Effectiveness [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
    The total reduction in fluoroscopy use with the non-fluoroscopic NavX mapping system approach is associated with a life-term ionizing radiation-exposure risk reduction, which will be estimated according to currently available ionizing radiation risk charts. Cost-effectiveness analysis will be performed taking into account such risk reduction, and the increased costs associated with the use of the nonfluoroscopic radiofrequency ablation approach.


Enrollment: 210
Study Start Date: December 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional catheter ablation
Radiofrequency catheter ablation through fluoroscopic guidance
Procedure: Radiofrequency catheter ablation
Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.
Experimental: Non-fluoroscopic catheter ablation
Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system
Procedure: Radiofrequency catheter ablation
Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female patients between 14 and 50 years of age who have received an indication to radiofrequency catheter ablation of supraventricular arrhythmias according to current guidelines.

Exclusion Criteria:

  • atrial fibrillation or non isthmus-dependent atrial flutter
  • pregnancy
  • hematological contraindications to ionizing radiation exposure
  • presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132274

Locations
Italy
Santa Maria della Misericordia - A.O. di Perugia
Perugia, PG, Italy, 06156
Arrhythmia Department, Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, Italy
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio
Pisa, PI, Italy
Institute of Cardiology; Presidio Ospedaliero Santa Chiara
Trento, TN, Italy
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan
Milan, Italy, 20138
Catholic University of the Sacred Heart
Rome, Italy, 00198
Sponsors and Collaborators
Catholic University of the Sacred Heart
St. Jude Medical Italy (Research Grant)
CNR Institute of Clinical Physiology, Pisa, Italy
Investigators
Principal Investigator: Michela Casella, MD, PhD Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan, Milan, Italy
  More Information

Publications:
Responsible Party: Michela Casella, MD, PhD, Cardiac Arrhythmia Research Centre, Department of Cardiovascular Medicine, Centro Cardiologico Monzino, University of Milan, Milan, Italy
ClinicalTrials.gov Identifier: NCT01132274     History of Changes
Other Study ID Numbers: UCSC210210
Study First Received: March 4, 2010
Last Updated: April 12, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
Supraventricular arrhythmia catheter ablation

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014